US9713690B2 - Methods and apparatus for pressure therapy in the treatment of sleep disordered breathing - Google Patents

Methods and apparatus for pressure therapy in the treatment of sleep disordered breathing Download PDF

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US9713690B2
US9713690B2 US12/192,247 US19224708A US9713690B2 US 9713690 B2 US9713690 B2 US 9713690B2 US 19224708 A US19224708 A US 19224708A US 9713690 B2 US9713690 B2 US 9713690B2
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pressure
flow
measure
threshold
respiratory
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US20090044805A1 (en
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Chinmayee Somaiya
Nicholas Ming Yun Yip
John David Oates
Adrian Barnes
Christopher Kingsley Blunsden
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Resmed Pty Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/087—Measuring breath flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A61M16/026—Control means therefor including calculation means, e.g. using a processor specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3365—Rotational speed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • the present technology relates to methods and apparatus for treatment of respiratory conditions such as the conditions related to obstructive sleep apnea hypopnea syndrome (OSAHS) or obstructive sleep apnea (OSA).
  • OSAHS obstructive sleep apnea hypopnea syndrome
  • OSA obstructive sleep apnea
  • Positive airway pressure may be delivered in many forms.
  • a positive pressure level may be maintained across the inspiratory and expiratory levels of the patient's breathing cycle at an approximately constant level.
  • pressure levels may be adjusted to change synchronously with the patient's breathing cycle.
  • pressure may be set at one level during inspiration and another lower level during expiration for patient comfort.
  • Such a pressure treatment system may be referred to as bi-level.
  • the pressure levels may be continuously adjusted to smoothly replicate changes in the patient's breathing cycle.
  • a lower pressure setting during expiration may generally be referred to as expiratory pressure relief.
  • a measure of patient respiratory flow may be utilized to detect when a patient changes from inspiration to expiration for determining when to deliver expiratory pressure treatment settings or inspiratory pressure treatment settings.
  • a measured patient respiratory flow signal may be utilized to detect patient flow limitation for purposes of making treatment pressure adjustments. Such adjustments are illustrated in the patent in U.S. Pat. No. 5,704,345.
  • a measured flow signal may be derived from a flow sensor such as a differential pressure transducer or pnuemotachograph.
  • a measure of pressure produced by a respiratory flow generating apparatus and a measure of a frequency of the respiratory flow generating apparatus are determined.
  • the method then derives an estimate of patient respiratory flow as a function of the measure of pressure and the measure of frequency.
  • the measure of frequency may be a rotational velocity.
  • the deriving of the estimate may further include determining an expected pressure as a function of the measure of frequency and may further include calculating a difference between the determined expected pressure and the measure of pressure.
  • Pressure treatment by the respiratory flow generating apparatus may be set or adjusted as a function of the derived estimate of respiratory flow.
  • the technology encompasses an apparatus for generating respiratory flow.
  • the apparatus may optionally include a patient interface to carry a flow of breathable gas to a patient.
  • the apparatus may further include a flow generator coupled with the patient interface to generate a flow of the breathable gas through the patient interface.
  • the apparatus may also include measurement sensors such as a pressure transducer to provide a pressure signal indicative of pressure in a portion of the patient interface or associated with the flow generator and a tachometer to provide a velocity signal indicative of a speed of the flow generator.
  • the apparatus may also be provided with a controller to control the flow generator. The controller is coupled with the pressure transducer to process the pressure signal and it is coupled with the tachometer to process the velocity signal.
  • the controller may be configured and adapted to control a method for estimating patient respiratory flow or to set delivered treatment pressure by a method as described herein such as by determining a measure of pressure with the pressure signal, determining a measure of frequency with the velocity signal and deriving an estimate of patient respiratory flow as a function of the measure of pressure and the measure of frequency.
  • a system for delivering respiratory flow to a patient includes an interface means to carry a flow of breathable gas.
  • the system may also include a flow means, coupled with the interface means, for generating the breathable gas.
  • the system may have a pressure sensing means for measuring pressure and for generating a pressure signal representing the measured pressure of the breathable gas as well as a frequency sensing means for measuring a frequency of the flow means and for generating a frequency signal representing the measured frequency.
  • the system will typically also include a processing means for processing the pressure signal and the frequency signal.
  • the processing means may be configured or adapted for processing a determination of a measure of pressure with the pressure signal, a determination of a measure of frequency with the frequency signal and a derivation of an estimate of patient respiratory flow as a function of the measure of pressure and the measure of frequency.
  • the processing means may also be configured for controlling a generation of pressure with the flow means as a function of the derived estimate of respiratory flow.
  • changes to pressure treatment may be delivered in synchrony with a patient's respiratory cycle without a flow sensor or utilizing a signal from a flow sensor.
  • methodology of the technology may be encoded on an information-bearing medium as software or firmware.
  • an information-bearing medium may include processor-readable information or processor control instructions.
  • the processor-readable information may control an apparatus for providing pressure treatment therapy.
  • the processor-readable information or processor control instructions may include steps that implement determining a measure of pressure produced by a flow generator, determining a measure of frequency of the flow generator and deriving an estimate of patient respiratory flow as a function of the measure of pressure and the measure of frequency.
  • FIG. 1 shows example components of an apparatus for respiratory flow estimation and pressure treatment based thereon
  • FIG. 2 is a flow chart for a method for a pressure treatment or flow estimation apparatus of the present technology
  • FIG. 3 is an illustrative input/output diagram for a control circuit or processor implementing flow estimation technology
  • FIG. 4 is a graph of an exemplary pressure treatment waveform implemented by a pressure treatment apparatus utilizing the present flow estimation technology
  • FIG. 5 is a diagram illustrating suitable components of a feedback control loop of a pressure treatment device utilizing flow estimation technology for mask swing adjustment.
  • the present technology may be implemented with a pressure treatment delivery device that may include a flow generator such as a servo-controlled blower 102 .
  • the blower 102 will typically include an air inlet and impeller driven by a motor (not shown).
  • a frequency sensor 104 is provided.
  • the sensor may be configured to measure the rotational velocity of the blower.
  • a tachometer may measure the revolutions per minute (RPM) of the blower's motor or the blower's impeller.
  • the frequency sensor 104 may be configured to generate a frequency signal f(t) indicative of the measurements of the sensor.
  • the device of FIG. 1 may further include a pressure sensor 106 , such as a pressure transducer.
  • the pressure sensor 106 is configured to measure the pressure generated by the blower 102 .
  • the pressure sensor 106 is proximate to the blower 102 but may be located downstream of the blower as desired.
  • the pressure sensor 106 generates a pressure signal p(t) indicative of the measurements of pressure.
  • the pressure sensor 106 and frequency sensor 104 have only been shown symbolically in FIG. 1 since it is understood that other configurations and other components may be implemented to measure the frequency and pressure associated with the blower 102 .
  • the pressure treatment delivery device will also typically include a patient interface such as an air delivery conduit 108 and a mask 110 to carry a flow of air or breathable gas to and/or from a patient.
  • the blower 102 can be coupled with the air delivery conduit 108 and the mask 110 so as to provide the breathable gas from the blower 102 .
  • Exhaust gas can be vented from the patient interface via an exhaust 111 .
  • the frequency f(t) and pressure p(t) signals may be sent to a controller or processor 112 .
  • Optional analog-to-digital (A/D) converters/samplers may be utilized in the event that supplied signals from the frequency and pressure sensors are not in digital form and the controller is a digital controller.
  • the controller may in turn generate blower control signals.
  • the controller may generate an RPM request signal to control the speed of the blower 102 by setting a desired frequency or rotational velocity set point and comparing it with the measured condition of the frequency sensor.
  • such changes may be based on determining a desired pressure set point and comparing it with the measured condition of the pressure sensor.
  • such changes to the motor speed are accomplished by increasing or decreasing supplied motor current with the servo based on determined differences between set and measured conditions such as in a closed loop feedback fashion and translating the difference to current.
  • the processor 112 or controller may make controlled changes to the pressure delivered to the patient interface by the blower 102 .
  • changes to pressure may be implemented by controlling the exhaust with a mechanical release valve (not shown) to increase or decrease the exhaust while maintaining a relatively constant blower speed.
  • the controller or processor 112 is typically configured and adapted to implement particular control methodology such as the methods described in more detail herein.
  • the controller may include integrated chips, a memory and/or other control instruction, data or information storage medium.
  • programmed instructions encompassing such a control methodology may be coded on integrated chips in the memory of the device or such instructions may be loaded as software or firmware using an appropriate medium.
  • the apparatus can be used for many different pressure treatment therapies, such as the pressure treatments previously mentioned, by adjusting a pressure delivery equation that is used to set the speed or pressure of the blower or the exhaust venting by the release valve.
  • an embodiment of the system may determine or estimate a patient respiratory flow, even without a flow signal from a flow sensor, and then adjust the pressure treatment delivered by the device based on patient respiratory conditions detected from or with the estimated flow signal. While the flow characteristics of the hose to the mask may also impact pressure determinations, such a flow estimation model can be based on the premise that in an rpm-controlled system the load perturbations (i.e., patient respiratory flow) are reflected in the pressure output of the device. Similarly, in a pressure-controlled system the load perturbations will be reflected in the rpm output of the device.
  • two measures such as pressure and flow generator system frequency (e.g., a rotational velocity of the blower such as RPM) taken together can give a measure of flow.
  • P RPM-derived may be determined or calculated by a static fan curve as follows:
  • a look up table may be pre-formed based on the above equations.
  • a suitable table may be pre-calculated based on a range of input measures of frequency and a range of input measures of pressure using the formulas.
  • the output of the table would then be a derived instantaneous flow value based on an input instantaneous measure of pressure and an input instantaneous measure of frequency as previously described.
  • the derived flow values may be determined from the difference between the measured pressure and the frequency derived pressure (e.g., P M ⁇ P RPM _ derived ).
  • FIG. 3 illustrates the flow estimate methodology with respect to a controller or processor 312 .
  • a measured pressure value signal 302 (p(t)) and a measured frequency value signal 304 ( ⁇ (t)) are input to a flow estimate algorithm 306 for deriving an estimated flow value signal 308 .
  • the flow estimate algorithm 306 is based on any of the calculations or functions as previously discussed such as one or more flow lookup tables 330 .
  • An estimate of flow (e.g., estimated patient respiratory flow) made by any of the methods discussed herein may then be used in any suitable flow-based determinations typically made by a pressure treatment device.
  • the derived flow estimate can be used to make a change in pressure upon detection of features of the patient respiratory cycle.
  • the derived flow estimate may be used to trigger an expiratory pressure relief.
  • a ratiometric trigger threshold such as a trigger threshold that is a function of the peak respiratory flow, may be utilized to detect the onset of expiration. Utilizing such a trigger in particular combination with any of the above estimates of flow that might deviate marginally from actual patient flow provides for a more reliable or resilient respiratory cycle detection and appropriate pressure response.
  • a bi-level pressure treatment therapy may be generated such that a reduced pressure level is delivered by the EPR during patient expiration and a higher treatment pressure level without the EPR reduction is delivered during patient inspiration.
  • the changes between an inspiratory level and an expiratory level may be gradual such that a smoother pressure change between the inspiratory pressure treatment levels and the expiratory pressure treatments may be effected.
  • FIG. 4 includes a plot of a patient simulation flow waveform 402 that has been generated by a patient flow simulation apparatus.
  • the patient flow simulation apparatus was coupled with the patient interface of a pressure treatment device that implements flow estimation technology described herein.
  • FIG. 4 also includes a graph of a pressure waveform 404 generated using the flow estimation and triggering technology discussed herein within the pressure treatment device. The graph illustrates that the device may deliver pressure adjustment in synchrony with the cycle of the patient simulation flow waveform 402 based on the estimated flow methodology.
  • a pressure treatment device can be affected by changes to pressure in the system introduced by the patient's respiratory cycle.
  • the sensors utilized for control of pressure levels to the mask of the patient interface are located proximate to the flow generator, rather than the mask of the patient interface, undesirable swings in mask pressure can be induced by the patient's respiration. These undesirable mask pressure swings can be adjusted with the controller to maintain more steady pressure levels by utilizing the present estimated patient flow technology.
  • the pressure treatment device controls pressure rather than controlling motor rpm and a pressure sensor used for the control is located at or proximate to the flow generator.
  • the measure of pressure that will be used in the feedback loop for pressure control is adjusted as a function of the estimate of flow. This adjustment is implemented in a predictive manner in an effort to impede mask swings induced by the patient's respiratory cycle.
  • this function of the estimate of flow may be multiplying the estimate by a value K, where K is a value that is different for positive flow (e.g., patient inspiration) and than for negative flow (e.g., patient expiration).
  • K is a value that is different for positive flow (e.g., patient inspiration) and than for negative flow (e.g., patient expiration).
  • the value for K may be experimentally chosen for positive and negative flow as desired to identify optimum values for swing reduction that generate more steady mask pressure in response to patient respiration.
  • PDF Pseudo Derivative Feedback
  • Controller components of such swing compensation control are illustrated in FIG. 5 .
  • An estimated flow value or signal is supplied to a measured pressure adjustor 550 along with a pressure value or signal measured by a pressure sensor 556 .
  • a pressure setting value or signal is supplied to the servo 552 along with an adjusted measured pressure value or signal. Based on these signals, the servo adjusts the motor current for controlling the output or speed of the motor 554 of the flow generator to thereby adjust the pressure delivered by the flow generator device to predictively reduce mask pressure swings induced by patient respiration.
  • swing compensation control may be implemented with a modified version of the swing control equation.
  • the pressure at the flow generator is controlled by comparing a desired pressure set point with the measurement from the pressure sensor.
  • the flow generator may be controlled so that a pressure set point is equal to a measure of pressure determined from a pressure sensor at the flow generator.
  • MeasuredPressure adjusted P M ⁇ FlowFactor
  • P M is a measure of pressure from a sensor such as a pressure transducer.
  • ImpedofDeliveryCir is the impedance of the delivery circuit or patient interface
  • Flow is an estimate of flow as previously determined.
  • K is a ratio of two impedances such as ImpedOfDeliveryCircuit divided by the ImpedanceOfTurbine.
  • Such an equation may then be implemented for swing compensation control in a pressure treatment delivery device of the present technology by controlling the respiratory treatment apparatus to generate pressure so that the adjusted measure of pressure meets a target or desired pressure setting.
  • the flow estimate technology may be implemented in a system utilized for detecting patient flow limitation or making other adjustments to the delivered treatment pressure of a pressure treatment device.
  • the flow estimate may be utilized in systems having a flow sensor.
  • the flow estimate technology described herein may serve as back up flow determination in the event of failure of a flow sensor that is used for flow based determinations.
  • the estimate of flow data may be combined with data from a flow sensor to generate combined flow data to insulate the system from more transient errors in either the flow signal from the flow sensor or the derived estimate of flow described herein.
US12/192,247 2007-08-17 2008-08-15 Methods and apparatus for pressure therapy in the treatment of sleep disordered breathing Active 2032-12-11 US9713690B2 (en)

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US12/192,247 US9713690B2 (en) 2007-08-17 2008-08-15 Methods and apparatus for pressure therapy in the treatment of sleep disordered breathing
US15/484,725 US20170216542A1 (en) 2007-08-17 2017-04-11 Methods and apparatus for pressure therapy in the treatment of sleep disordered breathing

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US96517107P 2007-08-17 2007-08-17
US12506608P 2008-04-22 2008-04-22
US12/192,247 US9713690B2 (en) 2007-08-17 2008-08-15 Methods and apparatus for pressure therapy in the treatment of sleep disordered breathing

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EP (2) EP2025358B1 (xx)
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CN (3) CN104524676B (xx)
AU (2) AU2008203812B2 (xx)
NZ (4) NZ573921A (xx)

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